Devices and methods for closure of transvascular or transcameral access ports

ABSTRACT

The present disclosure provides a variety of prostheses, delivery systems and techniques to facilitate closure of transvascular or transcameral access ports. Various embodiments of prostheses are provided including a plurality of radially expandable mesh discs filled with material to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation in part of and claims thebenefit of priority to International Application No. PCT/US2015/022782,designating the United States of America, filed Mar. 26, 2015, which inturn claims the benefit of priority to U.S. Provisional PatentApplication Ser. No. 61/971,458, filed Mar. 27, 2014 and U.S.Provisional Patent Application Ser. No. 62/083,192, filed Nov. 22, 2014.This patent application also claims the benefit of priority to U.S.Provisional Patent Application Ser. No. 62/326,710, filed Apr. 23, 2016.Each of the foregoing patent applications is incorporated by referenceherein in its entirety for any purpose whatsoever.

FEDERALLY-SPONSORED RESEARCH AND DEVELOPMENT

This invention was made with Government support under contract no.268201500012C awarded by the National Institutes of Health. The U.S.Government has certain rights in the invention.

BACKGROUND

Field of the Disclosure

The present disclosure relates to a device and method for transcathetercorrection of cardiovascular abnormalities, such as the delivery ofprosthetic valves to the heart. The present disclosure further relatesto implants for closing a caval-aortic iatrogenic fistula created by theintroduction of a transcatheter device from the inferior vena cava intothe abdominal aorta.

Description of Related Art

Transcatheter procedures have been a milestone advance in modernmedicine. Percutaneous or transthoracic catheters are advanced throughthe vascular system or other natural luminal orifices to effectmechanical remodeling through angioplasty or to effect occlusion orpatency or valvular function through implants of self-expanding orballoon-expanding occluders, stents, and valves. These procedures cantake the place of surgical repair in selected patients.

Percutaneous vascular occluders are limited because usually they requirethe operator to forego guidewire access between target chambers. Recentinnovations permit vascular occluders to be engineered around a centralguidewire lumen to enhance safety and versatility of the occluderprocedure.

Recently, Halabi and colleagues (JACC 2013; 61:1745), and thereafterGreenbaum and colleagues (Transcatheter therapeutics conference, SanFrancisco, 2013) reported a novel procedure to introduce large vasculardevices into the aorta from the adjoining inferior vena cava. Thisenabled transcatheter aortic valve replacement in patients otherwiseineligible because of no surgical access to the thorax and insufficientiliofemoral artery caliber. The “caval-aortic” access port, as it iscalled, was closed using nitinol occluder devices marketed by St JudeMedical (Amplatzer muscular ventricular septal defect occluder orAmplatzer duct occluder) to close congenital cardiovascular defects.These devices are inadequately hemostatic, do not allow uninterruptedguidewire access, and are imperfectly suited for this application.

Transcatheter structural left heart procedures are generally performedthrough the femoral artery. However, femoral artery caliber orintravascular disease precludes or complicates vascular access in asignificant minority of candidates for transcatheter aortic valvereplacement or aortic endograft therapy. Moreover, the most frequentlife-threatening complication of TAVR is vascular complications of largeintroducer sheaths placed in the femoral artery. Alternativetranscatheter approaches to the heart would therefore be desirable. Thepresent disclosure provides solutions for these and other problems asdescribed herein.

SUMMARY OF THE DISCLOSURE

The purpose and advantages of the present disclosure will be set forthin and become apparent from the description that follows. Additionaladvantages of the disclosed embodiments will be realized and attained bythe methods and systems particularly pointed out in the writtendescription hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the disclosure, as embodied herein, in one aspect, the disclosureincludes embodiments that solve problems of caval aortic access based onconsiderable pre-clinical, animal, imaging, and clinical experience incaval-aortic access. These approaches differ substantially from theaforementioned prior art.

In certain embodiments, the problem of variable distance between aorticand caval access points is solved using a telescopic design as disclosedherein. The problem of inadequate hemostasis of aortic and caval accesstracts, in some implementations, is solved using “billowing” nitinolweave to fill the vascular holes and by using multiple disks to occludeeach vascular rent.

In some implementations, a prosthesis is provided that can include aradially expandable mesh body that is configured to self-expand into atleast one disc after becoming radially unconstrained, the radiallyexpandable mesh body defining a volume therein when expanded. Theprosthesis can further include a resilient member disposed within themesh that is attached to a proximal end and distal end of the prosthesisalong an axis that defines a central region of the prosthesis. Theresilient member can be configured to cause the prosthesis to shortenalong the axis and expand radially when the resilient member is relaxed.

The prosthesis can include a material disposed within the mesh that isconfigured to encourage coagulation when exposed to blood. For example,the material disposed within the mesh can include first and secondfabric discs that are disposed within the at least one disc of theradially expandable mesh body to line the radially expandable mesh bodywith fabric. If desired, the prosthesis can further include a tubularfabric portion attached to at least one of the fabric discs. The tubularfabric portion can extend proximally into a neck region of theprosthesis.

In some implementations, the resilient member can be a coil spring thatcauses the prosthesis to collapse axially and the at least one disc toexpand radially to prevent the prosthesis from being pulled axiallythrough an opening it has been inserted through after it has beendeployed. The resilient member can be a tension coil spring, among othermaterials. The coil spring can include at least two sections ofdifferent diameter. If desired, the coil spring can include at leastthree sections of different diameter. In some implementations, the coilspring can include at least three sections wherein each section has adiameter different than an adjacent section. If desired, the coil springcan include an enlarged central section for causing a neck portion ofthe prosthesis to bulge radially outwardly when the prosthesis isdeployed.

If desired, the radially expandable mesh body can be configured toself-expand into at least two discs connected by the neck region afterbecoming radially unconstrained. A first disc of the two discs can beconfigured to mitigate high pressure leaks in an artery. A second discof the two discs can be configured to mitigate low pressure leaksoriginating from a vein. The neck region can be configured to cooperatewith the first and second discs to prevent leakage from the artery andthe vein. At least one of the discs can include a plurality of radiallyoriented struts attached to the mesh of the at least one disc to enhancethe axial compressibility of the prosthesis. The prosthesis can includeone or more radially oriented struts attached to the discs at the distaland proximal faces of the prosthesis, that can extend from a radiallycentral portion of the prosthesis to an outer periphery of theprosthesis.

Thus, in some embodiments, the disclosure provides a system fordelivering a prosthesis. The system can include one or more of an outertubular sheath having a proximal end and a distal end and defining afirst lumen therethrough along its length, an intermediate tubularmember disposed at least partially within the first lumen, and having aproximal end and a distal end and defining a second lumen therethroughalong its length. The system can include an inner elongate memberdisposed at least partially within the second lumen, and having aproximal end and a distal end. The system can further include aprosthesis removably mounted on the distal end of the intermediatetubular member. The prosthesis can include a radially expandable meshbody that is configured to self-expand into at least one disc afterbecoming radially unconstrained, the radially expandable mesh bodydefining a volume therein when expanded. The prosthesis can furtherinclude a resilient member disposed within the mesh that is attached toa proximal end and distal end of the prosthesis along an axis thatdefines a central region of the prosthesis. The resilient member can beconfigured to cause the prosthesis to shorten along the axis and expandradially when the resilient member is relaxed. Distal movement of theinner tubular member against a portion of the prosthesis can cause it tocollapse radially and elongate axially so as to permit the prosthesis tobe collapsed after deployment, adjusted and redeployed or retracted intothe outer tubular member and removed.

If desired, the inner elongate member can be a tubular member, such as ahypotube or polymeric tubular member or composite tubular memberconfigured to permit a guidewire to pass therethrough. The resilientmember can be a coil spring, that causes the prosthesis to collapseaxially and the at least one disc to expand radially to prevent theprosthesis from being pulled axially through an anatomical opening ithas been delivered through after it has been deployed.

In some implementations, the resilient member can be a tension coilspring, among other alternatives such as an elastic material or otherresilient material that regains some or all of its original length afterbeing elongated axially. In some implementations, a distal end of theouter tubular member can be cut at an angle that is oblique with respectto a central axis defined by the system. The system can include asteering mechanism to articulate the distal end of the outer tubularmember, such that the oblique cut of the distal end of the outer tubularmember can facilitate navigation of the distal end of the system, suchas through a caval-aortic iatrogenic fistula created by the introductionof a transcatheter device from the inferior vena cava into the abdominalaorta.

If desired, the coil spring can include an enlarged central section forcausing the neck portion of the prosthesis to bulge radially outwardlywhen the prosthesis is deployed. In some implementations, the radiallyexpandable mesh body can be configured to self-expand into at least twodiscs connected by the neck region after becoming radiallyunconstrained. A first disc of the two discs can be configured tomitigate high pressure leaks in an artery. A second disc of the twodiscs can be configured to mitigate low pressure leaks originating froma vein. If desired, the neck region can be configured to cooperate withthe first and second discs to prevent leakage from the artery and thevein. In some implementations, the prosthesis can include a materialdisposed within the mesh that is configured to encourage coagulationwhen exposed to blood.

The disclosure further provides various prostheses including a radiallyexpandable mesh body that is configured to self-expand into at least onedisc after becoming radially unconstrained, the radially expandable meshbody defining a volume therein when expanded. The prosthesis furtherincludes at least one tether attached to the radially expandable meshbody that is configured to cause the radially expandable mesh body tocollapse radially when tension is applied to the at least one tether.

If desired, the radially expandable mesh body can be configured toself-expand into at least two discs connected by a neck region afterbecoming radially unconstrained. A first disc of the two discs can beconfigured to mitigate high pressure leaks in an artery. A second discof the two discs can be configured to mitigate low pressure leaksoriginating from a vein. The neck region can be configured to cooperatewith the first and second discs to prevent leakage from the artery andthe vein.

In some implementations, the radially expandable mesh body can beconfigured to self-expand into at least three discs connected by twoneck regions after becoming radially unconstrained. A first disc of thetwo discs can be configured to mitigate high pressure leaks in anartery. A second disc of the two discs can be configured to mitigate lowpressure leaks originating from a vein. The neck region can beconfigured to cooperate with the first and second discs to preventleakage from the artery and the vein.

If desired, the radially expandable mesh body can be configured toself-expand into at least four discs connected by three neck regionsafter becoming radially unconstrained. A first disc of the two discs canbe configured to mitigate high pressure leaks in an artery. A seconddisc of the two discs can be configured to mitigate low pressure leaksoriginating from a vein. The neck region can be configured to cooperatewith the first and second discs to prevent leakage from the artery andthe vein. If desired, the at least one tether can be threaded throughall of the discs to cause all of the discs to collapse radially inwardlyupon applying sufficient tension to the at least one tether. In someimplementations, the prosthesis can include a material disposed withinthe mesh that is configured to encourage coagulation when exposed toblood.

In further accordance with the disclosure, any prosthesis disclosedherein can be formed at least in part from a composite wire. In someembodiments, the composite wire can be drawn filled wire. For example,the drawn filled wire can include a first material, and a secondmaterial in a different region of the drawn filled wire that has greaterradiopacity than the first material. The first and second materials caninclude metallic components and/or bioresorbable components. If desired,the second material can be located along a core region of the wire, andfirst material can surround or substantially surround the firstmaterial. The first material can include a NiTi alloy, and the secondmaterial can include platinum, for example.

In further implementations, the disclosure provides an implantableprosthesis that includes an inflatable bioresorbable body having aproximal end and a distal end, the body being configured to be expandedradially by directing fluid into the body. The prosthesis further caninclude at least one radially expandable strut attached to each of theproximal end and distal end of the body. Each of the struts can beconfigured to expand outwardly to prevent the prosthesis from beingpulled through an anatomical opening into which it has been inserted.

If desired, the aforementioned prosthesis can further include a couplinglocated at the proximal end of the prosthesis configured to be attachedto a delivery system. The coupling can be configured to permit inflationfluid to pass therethrough.

In a further embodiment, a prosthesis is provided as described hereinhaving a mesh body that is configured to self-expand into at least twodiscs connected by a neck region after becoming radially unconstrained.A first disc of the at least two discs can be configured to mitigateleaks, and a second disc of the at least two discs can be configured tocause appropriate positioning of the prosthesis in the presence ofcardiovascular motion. Such a prosthesis can be used, for example, toaddress high pressure leaks from an artery or a cardiac chamber. In someimplementations, such a prosthesis can be used to address a ventricularseptal defect (VSD) (i.e., a hole in the heart). This is a common heartdefect that's present at birth (congenital). The hole occurs in the wallthat separates the heart's lower chambers (septum) and allows blood topass from the left to the right side of the heart. The oxygen-rich bloodthen gets pumped back to the lungs instead of out to the body, causingthe heart to work harder. The prosthesis can be delivered and deployedinto the defect and deployed, sealing the hole.

In further embodiments, such a prosthesis can be used for varioustranscardiac applications, wherein the second disk assures retention inposition of the prosthesis. For example, such a prosthesis can be usedto seal an access opening through the aortic arch that is formed foraccessing the aortic valve after the valve is replaced. Similarly, suchan approach can be used to seal openings formed in lumenal or vascularwalls such as apical access procedures for sealing openings formedthrough the ventricular wall, for sealing openings formed in a septum(e.g., patent foramen ovale (PFO)) and the like.

Unique benefits of the disclosed prosthesis and delivery system includethat the prosthesis can be adjusted, or even removed after beinginstalled in a vascular opening, for any desired reason. Thus, in someembodiments, the disclosure provides a method that includes a deliverysystem as described herein including a prosthesis as disclosed hereinmounted thereon, delivering the delivery system over a guidewire routedto a target location, and fully deploying the prosthesis at the targetlocation to obstruct a vascular opening to be sealed. The prosthesis canthen be detached from the delivery system. The delivery system can thenbe withdrawn over the guidewire after the prosthesis has been detachedtherefrom. Then, if desired, the delivery system can be once againadvanced over the guidewire after withdrawing it, and the prosthesis canbe reattached to the delivery system. A further step can then beperformed with the prosthesis including at least one of: (i) partiallycollapsing the prosthesis, (ii) repositioning the prosthesis, and (iii)collapsing and withdrawing the prosthesis into the delivery system, andremoving the delivery system and prosthesis over the guidewire. Thedisclosed method is facilitated by the use of a pushrod (preferably atubular pushrod) as disclosed herein.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the embodiments disclosed herein.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the method and system of the disclosure. Together withthe description, the drawings serve to explain the principles of thedisclosed embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, aspects, features, and advantages ofexemplary embodiments will become more apparent and may be betterunderstood by referring to the following description taken inconjunction with the accompanying drawings, in which:

FIGS. 1A-1D depict a distal portion of an illustrative delivery systemfor delivery of a prosthesis for closure of transvascular ortranscameral access ports and the prosthesis itself.

FIGS. 2A-2D illustrate various aspects of the prosthesis delivered bythe device of FIG. 1.

FIG. 3A illustrates an embodiment of a further prosthesis in accordancewith the disclosure.

FIGS. 3B-3C illustrate examples of prior art prostheses.

FIGS. 4A-4C illustrate a further embodiment of an implantable device inaccordance with the disclosure mounted on the distal end of a deliverysystem.

FIG. 4D illustrates a further embodiment of an implantable device inaccordance with the disclosure.

FIGS. 5A-5C illustrate a prosthesis mounted on the distal end of adelivery system, showing articulation of the delivery cable shaft.

FIGS. 6A-6C illustrate variations of windings that can be used to helpform the prosthesis.

FIG. 7-8 illustrates a portion of a delivery system in accordance withthe disclosure without a prosthesis mounted thereon and with an outerportion of the system removed.

FIG. 8 is an illustration of an exemplary embodiments of a deliverysystem with a prosthesis mounted thereon.

FIGS. 9A and 9B illustrate a further adjustable, compliant,maneuverable, retrievable and repositionable four disc/lobe closuresystem.

FIGS. 10A-10B illustrate a three disc/lobe embodiment wherein a centraldisc is located between the aorta and inferior vena cava.

FIG. 11A-11B illustrate a four disc and three disc embodiment of aprosthesis.

FIG. 12A-12B illustrate the prosthesis in a deployed condition with theend disc flattened.

FIG. 13A-13B illustrate the prosthesis in a deployed condition with theend disc flattened.

FIG. 14A-14B illustrate the prosthesis and delivery catheter withtethers running through all four and three prosthesis and into a guidingsheath of the delivery catheter.

FIGS. 15A-15B and FIGS. 16A-16B illustrate a complete deployment of athree disc embodiment from beginning to end.

FIGS. 17-22 present a further illustrative embodiment of a telescopicclosure prosthesis in accordance with the disclosure and method of usethereof.

DETAILED DESCRIPTION

Reference will now be made in detail to the present preferredembodiments of the disclosure, examples of which are illustrated in theaccompanying drawings. The method and corresponding steps of thedisclosed embodiments will be described in conjunction with the detaileddescription of the system.

The exemplary embodiments illustrated herein can be used to moreeffectively close transvascular or transcameral access ports.

For purposes of illustration, and not limitation, as embodied herein andas illustrated in FIG. 1, a delivery system 200 is provided includingprosthesis 100 mounted thereon. An illustration of a full exemplarysystem can be seen in each of FIG. 7 and FIG. 8, which are discussed infurther detail below.

As referred to herein, the term “prosthesis” is intended to refer to astructural element that may or not be resorbable in whole or in partthat can be used to replace a portion of anatomy and/or to close anopening in anatomy, particularly within the vasculature of thecardiovascular system. The prosthesis typically includes an adjustableframework or other body that can be used to close the openings invasculature.

As illustrated, the distal region of the system 200 includes a distalend of an outer tubular member 124 that can be introduced through alumen of a guiding catheter (not shown) that is used to deliver aprosthesis or perform some other function via a transvascular ortranscameral access port. The distal end of the outer tubular member 124is preferably provided with a distal radiopaque marker 120, such as onemade at least in part from silver, gold, platinum or other radiopaquematerial, as desired. The distal tip 122 of the outer tubular member canbe cut on a bevel and be provided with a marker that is aligned with thebevel near the beveled tip to facilitate guiding the device across thewall of the inferior vena cava into the aorta, for example. The bevelmay be at any suitable angle, but is preferably offset from a centralaxis of the catheter by an angle between about 30 degrees and aboutsixty degrees, or any angular increment therebetween of about onedegree. In an illustrative embodiment, the angle can be about 45degrees. It has been found that such beveling of the tip helps to reduce“canting” or undesirable tilting of the implant during installation. Theouter tubular member can be articulable or steerable at its distal endto facilitate maneuverability of the system. However, as discussedfurther below, the intermediate member 118 is preferably flexible, andcan help eliminate the need for a steerable outer tubular member.

Outer tubular member 124 may be made from a variety of materials. Forexample, the sheath 120 can include a multi-layered co-extrusion, suchas those described in U.S. Pat. No. 6,464,683 to Samuelson or U.S. Pat.No. 5,538,510 to Fontirroche. Each of the aforementioned patents isincorporated by reference herein in its entirety.

Any surface of various components of the catheters described herein orportions thereof can be provided with one or more suitable lubriciouscoatings to facilitate procedures by reduction of frictional forces.Such coatings can include, for example, hydrophobic materials such asPolytetrafluoroethylene (“PTFE”) or silicone oil, or hydrophiliccoatings such as Polyvinyl Pyrrolidone (“PVP”). Other coatings are alsopossible, including, echogenic materials, radiopaque materials andhydrogels, for example.

Within the outer tubular member 124 of the delivery system 200 a tubulardelivery cable, or intermediate tubular member 118, is slidably disposeddefining therethrough a central lumen along its length for slidablyreceiving a pushrod 180 therethrough, discussed in detail below. Adistal region of the intermediate tubular member 118 can be configuredto be of a lower stiffness, or durometer, than a proximal region of thecable to make it easier to articulate the distal end of the system, suchas embodiments wherein the outer tubular member 124 have an articulabledistal end or region. As illustrated, the intermediate tubular member118 terminates in a coupling 116 for attachment to the prosthesis 100.The illustrated coupling 116 is a female member that receives acorresponding male coupling portion 114 on the prosthesis 100, but itwill be appreciated that the coupling 116 on the delivery system can bemale and that the coupling on the prosthesis can be female. In someimplementations, a female coupling can be provided on the prosthesisthat is defined by the inside of a coiled member, discussed in furtherdetail below, that is received by a male threaded coupling on thedelivery system. The coupling may be a threaded coupling but can also bea twist and lock coupling or the like.

As further illustrated in FIGS. 1A-1B, a first exemplary embodiment of aprosthesis 100 is provided having a proximal end that connects to thedelivery system, and a distal end 104 through which a guidewire canextend via a guidewire lumen 106. As illustrated, the prosthesis 100includes an interior coil tension spring 101 that is configured to becontracted into a relaxed state when not being stretched. This resultsin the prosthesis being in a shortened, compressed state when relaxed.This is most evident in FIG. 1C, showing a compressed prosthesis 100when the tension spring 101 is in a relaxed, unelongated condition. Bystretching the coil spring, such as by pulling both ends of theprosthesis apart, the prosthesis takes on a more elongated profile witha smaller radial profile, such as depicted in FIG. 1A or 2C.

The coil spring 101 can have a substantially uniform outer and innerdiameter along its length from a proximal end of the prosthesis to thedistal end of the prosthesis. Alternatively, as illustrated in FIG. 6A,the coil spring 101 can have a first portion that has a larger diameterthan a second portion, wherein the smaller diameter portion can bedirected toward the proximal or distal end of the prosthesis. Asillustrated in FIG. 6B, the coil spring can have three regions ofdifferent diameters, wherein a central region of the coil spring canhave an enlarged diameter with respect to the diameter of either endportion. The end portions can be of the same or different diameters.Having an enlarged central portion can help prevent leakage after theprosthesis is installed as the coil can urge against the graft and/ormesh material within the adjustable neck 110 region of the deployedprosthesis between the lumens to cause the neck to bulge outwardlyagainst the outer lumen walls to facilitate sealing and to help preventleakage. The windings of the coil spring that is attached to the highpressure disc on the distal end of the prosthesis can be sized andshaped to prevent the hypotube from passing out of the distal end of theprosthesis, but to permit the guidewire to pass through. Similarly, theportion of the coil spring at the proximal end of the prosthesis thatfaces the delivery system can have a coil spring that is configured tobe threaded onto a male end of the intermediate tubular member 118 toattach the prosthesis to the delivery system.

It will be appreciated that while a coil spring is primarily illustratedherein and is preferred, other resilient or elastic members can be usedin place of the coil spring, or the prosthesis may instead be providedwith retractable tethers (discussed in detail below with respect to FIG.9 onward). For example, a single or a loop Elastic band that is attachedto the radially expandable discs can be used, and/or any suitablematerial that can act as a tension spring and have a suitably lowprofile.

The prosthesis 100 further includes a mesh covering that may be braidedfrom a variety of materials such as NiTi alloys or bioresorbablematerials. It should be noted that, in some implementations, theprosthesis can be made from bioresorbable materials in its entirety.Suitable bioresorbable materials and techniques for construction can befound, for example, in U.S. patent application Ser. No. 11/398,363,filed Apr. 4, 2006, and U.S. patent application Ser. No. 14/461,159,filed Aug. 5, 2014, each of which is incorporated by reference herein inits entirety for any purpose whatsoever.

The mesh covering preferably defines at least one proximal lobe, or disc112 and at least one distal lobe, or disc 102 joined by a narrowed neck110 region that can be adjustable in radial dimension so as to permit acustom fit during implantation to minimize or eliminate leakage from theaorta and IVC. The mesh covering is joined at each of the proximal anddistal ends to the respective proximal and distal ends of the coilspring. If desired, the disc 102 can be a high pressure endolumenal discconfigured for placement against an inner arterial wall and disc 112 canbe a low pressure disc configured for placement, for example, against aninner wall of the inferior vena cava.

The interior of the mesh can be filled with a woven graft material 108and/or an elastomer with a coagulating coating, such as polyethyleneglycol (PEG), or other non-thrombogenic, bio-inert polymer or polymerprecursor.

For example, as illustrated in FIG. 1D, which presents a cross sectionof prosthesis 100, the distal face of the distal lobe or disc caninclude a first disc shape graft portion 108 a that has a continuoussurface except for a small hole or aperture 108 b at the center thereoffor surrounding the distal end of the coil spring 101 where it meets themesh to permit the guidewire to pass through the distal end of theprosthesis. This first disc shaped portion 108 a can be joined about itsouter periphery (e.g., by weaving or stitching) to a second disc shapedportion 108 c which also defines therein a central aperture 108 d whichmay be slightly larger than 108 b to permit passage therethrough of thecoil spring which in turn is sized and shaped to permit passagetherethrough of a pushrod (e.g., a stainless steel or NiTi hypotube, orpolymeric (e.g., PEEK) or composite (e.g., carbon fiber) tubular member)of the delivery system containing the guidewire (discussed below). Afurther tubular graft portion 108 e can be attached to and depend in aproximal direction from the proximal face of second disc shaped portion108 c to line the neck region of the prosthesis 100 and to surround thecentral region of the coil spring 101. If desired, portion 108 e can bestitched at one or more locations to the mesh structure. In someimplementations, the graft material 108 can still further include athird disc-shaped portion 108 f attached to the proximal end of tubularportion 108 e also defining a central aperture therein 108 g forpermitting passage of the coil 101. Disc 108 f can similarly be joinedabout its periphery via weaving or stitching to a fourth, proximal disc108 h defining therein a central aperture 108 i, which in turn surroundsthe proximal end of the spring where it meets the proximal portion ofthe mesh to seal around the spring. The outer periphery of the fouraforementioned discs may be stitched to each other and to the mesh toensure proper registration of the mesh with the graft material.

As further illustrated in FIG. 1C, a pushrod 180 is slidably disposedwithin the lumen of the intermediate tubular member 118. The pushrodincludes a proximal end attached to an articulable proximal handle (seee.g., FIGS. 7 and 8) and a distal end that abuts an inner surface of thedistal end portion of the prosthesis 100. Specifically, the distalcentral opening of prosthesis 100 is large enough to permit a guidewireto pass therethrough, such as between 0.010 and 0.060 inches or othersuitable diameter. Preferably, the aperture is small enough for thedistal end of the pushrod 180, which defines a central lumen to slidablyhouse the guidewire, to not pass through the opening, and instead urgeagainst the inner distal surface of the prosthesis. Instead, the distalend of the pushrod (or push tube, as desired), abuts an inner distalsurface of the prosthesis at or near the location of the opening. Forexample, the inner distal surface of the prosthesis can define ashoulder about the opening that the push rod pushes against, or ifdesired, the windings of spring 101 can be such that the most distalwindings permit the guidewire to pass through, but not the push rod/pushtube.

FIG. 2A is a schematic cross sectional representation of the prosthesis100 in an extended or longitudinally stretched state wherein the coilspring 101 is in a stretched condition, and FIG. 2B illustrates theprosthesis in a relaxed condition in situ after installation grippingboth sides of a lumenal passage. FIG. 2C similarly depicts an outer viewof a prototype prosthesis 100 in an expanded condition wherein the pushrod/push tube is urged distally within the delivery system (not shown)against the distal end of the prosthesis to cause the coil spring tostretch longitudinally. FIG. 2D illustrates the same prosthesis in arelaxed condition after the push rod/push tube is withdrawn. As can beappreciated, the coil spring 101 forces each of the lobes or discsincluding the exterior mesh with graft material inside to flatten andbetter contact the wall of the vessel (or chamber, depending on theapplication) and thereby better achieve hemostasis.

FIG. 3 illustrates relative performance between a disclosed embodimentand prior art embodiment. For example, an exemplary embodiment having afirst disc section constructed as described above is presented in FIG.3a . This embodiment resists pull-through the lumenal or chamber wallbecause the spring, or elastic member, is attached to the center of thedistal or “high-pressure” disk (that could be located within an artery,for example), which causes the distal disk to flatten. Prior artembodiments (FIGS. 3B & 3C), such as Amplatzer Duct Occluder product,does not have such an elastic member or spring, and therefore assumes anoblong configuration during the retraction phase of deployment (arrow)and therefore is susceptible to inadvertent pull-through, whichnaturally leads to a potentially dangerous situation for the patient.

FIGS. 4A-4C illustrate a further embodiment of a prosthesis that, inaddition to having all of the aforementioned structural features,additionally include additional elongate radially oriented struts or“wings” 136, 138 that are attached to the mesh of the prosthesis at thedistal and proximal faces of the prosthesis, extending from a radiallycentral portion of the prosthesis to an outer periphery of theprosthesis. These struts enhance the collapsibility of the prosthesisunder the action of the spring or elastic member. While these wings orstruts can be constructed as loops, they can be made in any desirable orsuitable manner. FIG. 4A illustrates such a prosthesis in alongitudinally expanded configuration wherein the mesh envelope isstretched longitudinally over the graft material and spring, whereasFIG. 4B illustrates the prosthesis in a relaxed condition wherein it canseal against one or more lumenal walls. FIG. 4C further illustrates theprosthesis in a fully longitudinally expanded configuration wherein thepush rod/push tube is fully extended causing the prosthesis to collapseradially inwardly so that it can be inserted into a delivery sheath.Significantly, this design permits the device to be retrieved andremoved, or removed and repositioned and reimplanted and moved asdesired. In other words, the combination of the elastic member or springand delivery system with a push rod or push tube greatly enhancesdeliverability and placement of the prosthesis.

FIG. 4D illustrates an alternative embodiment of a prosthesis 140 thatincludes a main body formed from an inflatable, preferably bioresorbablematerial that is configured to seal a transcameral or transvascularaccess port, or other anatomical opening to be sealed. As illustrated,the prosthesis 140 has a proximal end attached to coupling 114 that inturn is removably attached to a coupling 116 located at the distal endof the intermediate tubular member 118. A lumen (not visible) passingthrough member 118 can carry fluid therethrough for inflating prosthesis140 during delivery. Fluids, such as biodegradable polymer, resin orsaline can be used to inflate prosthesis 140.

Fluid ports (not visible) can be provided in each of members 114, 116 tofacilitate the inflation. Optionally, a guidewire port 106 canadditionally be included. Wings 136, 138 can also be included to holdagainst the interior surfaces of the aorta and inferior vena cava, forexample, while the inflatable body of the prosthesis 140 spans the gapbetween the two vessels and protrudes slightly into each vessel. Theprosthesis 140 can be radially compressed within the distal end of outertubular member 124 as with prosthesis 100. The compressed prosthesis 140can be delivered to the site at which it is to be implanted, and thewings 136 can be deployed inside the aorta, for example, or other firstlocation. The outer tubular member/sheath 124 can be retractedproximally thereby exposing the entire prosthesis 140 to the surroundinganatomy. A fluid actuator (e.g., fluid plunger that is actuated linearlyor rotationally with a rotating handle driving screw) can then bedepressed/actuated causing inflation fluid to be directed through thedelivery system and into the prosthesis 140. The prosthesis 140 can beinflated to a desired extent to block leakage, and the wings 138 can bedeployed (before, during or after inflation), causing the prosthesis tobe lodged within the desired location. The wings/struts 136/138 could bewire loops that pass through the body of prosthesis, or can be mountedon either end of the prosthesis 140. Wings 136/138 are preferably shapedso they can be easily collapsed and retrieved into the delivery system.

If it is desired to move or remove the prosthesis 140, the fluid can beevacuated from the prosthesis by moving the fluid actuator in theopposing direction. The prosthesis can then be repositioned andimplanted, or withdrawn into the distal end of outer tubular member 124,as desired. If desired, a push rod or push tube can be used to assist inretrievability of the prosthesis 100.

FIGS. 5A-5C further illustrate an embodiment of the prosthesis in acollapsed state on a delivery system in various articulated/steeredpositions allowing for adapting to the oblique angle of the devicenecessary for deployment and final release of the device.

FIG. 7 is an end to end illustration of a portion of an example ofdelivery system in accordance with the disclosure without the prosthesismounted thereon and with the outer tubular member removed. As can beseen in FIGS. 7 and 8, the device itself, as well as the outer tubularmember, intermediate tubular member, and push rod or push tube each haveproximal end attached to a handle or control knob and a distal end. Theintermediate tubular member as illustrated in FIG. 7 includes arelatively stiff proximal portion attached to a back end 150, and atransition segment 148 that is in turn attached to a distal flexiblesegment that terminates in coupling 116.

As illustrated in FIG. 8, the outer tubular member 124, or main deliverycatheter, includes a back end 160 including a handle and steering knobconfigured to articulate the distal end of main delivery catheter/outertubular member 124 that is attached to a proximal tubular region whichin turn is connected to a distal tubular region terminating in beveledtip 122 that preferably also includes a marker that tracks the bevel tofacilitate installation and reduce canting, or tilting, of theprosthesis during installation. The actuator 160 can take on a varietyof forms, such as those depicted in U.S. Pat. No. 6,488,694 to Lau andU.S. Pat. No. 5,906,619 to Olson, the specifications of which areincorporated herein by reference in their entireties.

Before the system is introduced into the patient via a guiding catheter(not shown), the push rod 180 is fully distally extended to radiallycollapse the prosthesis, after which the intermediate tubular member canbe withdrawn into the distal end of the main delivery catheter 124. Theintermediate tubular member 118, or delivery cable shaft, thuspreferably has variable stiffness along its length with a softer distalsegment allowing for adapting to the oblique angle of the devicenecessary for deployment and final release of the device.

However, the present disclosure provides additional embodiments. Forexample, if desired, the prosthesis can be provided with more than twodiscs or lobes.

For purposes of illustration, and not limitation, FIGS. 9A and 9Billustrate a further adjustable, compliant, maneuverable, retrievableand repositionable four disc/lobe closure system that resembles the twolobe system discussed above, except that two additional discs or lobesare provided between the proximal and distal lobes. While the discs aredepicted as being formed from a NiTi alloy, it will be appreciated thatany suitable material can be used.

As illustrated in FIGS. 9A and 9B, in an installed formation, theprosthesis includes a first high pressure or artery facing disc 16 thatis deployed in the aorta, for example. The caval wall 4 and arterialwall 2 are presented with the prosthesis mounted therein. A nextproximal disc 12 is provided for deployment against the outer wall ofthe aorta. A marker band 6 is also provided to enhance retention of theprosthesis. A third external caval disc 10 is provided for urgingagainst the exterior of the inferior vena cava, and a fourth disc 8 isprovided to seat within the IVC. One or more of the four discs can beprovided with an exterior curvature or taper 14 that facilitatessealing, and all four discs can be formed from a mesh as with embodiment100. A spring need not be located within the prosthesis of FIG. 9, butit can be. Collapsing of the prosthesis can be facilitated with tethers62 that run through all four and three prosthesis and into a guidingsheath 64 of the delivery catheter as illustrated in FIG. 14A-B. Asillustrated in FIGS. 16A-B, the tethers can be withdrawn and pulled andthe delivery catheter can be held fast to tighten the tethers until allleaks are stopped. The tethers can then be tied off or clipped, and thedelivery system can be removed accordingly.

FIG. 9A shows the prosthesis after deployment but before the tethers arecinched, while FIG. 9B shows the tethers after cinching. FIGS. 10A-Bsimilarly show a three disc/lobe embodiment wherein a central disc 28 islocated between the aorta and inferior vena cava. The construction isotherwise the same as the embodiment of FIG. 9, and may be constructedwith an interior spring if desired as with embodiment 100 if desired,and/or can be provided with tethers as the embodiment of FIGS. 9A-9B.The embodiment of FIGS. 10A-B may also be provided with a guidewirelumen 30.

FIG. 11A depicts a four disc embodiment of a prosthesis wherein aradiopaque and/or elastomer covered neck 36 is provided between the highpressure disc 38 and the second disc 12, wherein the elastomer 34 isdesigned to help prevent leakage. Also visible are the low pressurecaval disc 40 and third disc 10, wherein discs 10, 12 and 40 each haveradiopaque markers disposed therebetween. FIG. 12A shows the prosthesisin a deployed position wherein the end discs are flattened and themiddle discs are not fully flattened. FIG. 11B similarly provides athree disc version wherein like reference numbers indicate likestructures.

FIG. 12A illustrates a four disc embodiment in a deployed conditionwherein the caval disc 50 and aortic disc 52 are compressed and fixed,and the intermediate discs 10, 12 are expanded to express a taper 14 tofacilitate sealing and prevent leakage. FIG. 12B illustrates a threelobed prosthesis wherein the caval 52 and aortic 50 discs are fullydeployed and flattened, and further wherein the central disc 28 isdeployed to define a tapered sealing surface 14. FIGS. 13A-B show afurther variant of a four disc embodiment in a semi deployed conditionand in a simulated installed condition in anatomy.

FIGS. 14A-14B illustrate four and three disc prosthesis embodimentsrespectively with tethers 62 routed through them, wherein the aorticdisc 16 is located at a distal end of the assembly, and a most proximatedisc 8 is also provided. The tethers 62 are directed through theprosthesis, and then proximally through a tubular member, or tetherlumen 64, toward the proximal end of the delivery system 68 through aport and/or handle 66. A handle 70 is further provided that is attachedto an elongated member or closure holding shaft 72 (e.g., tube or rod)that is attached to the prosthesis via a removable coupling, such as aholding, releasing and/or retrieval articulating screw with wire lumen.FIGS. 15-16 show a complete deployment of a three disc embodiment frombeginning to end.

FIGS. 17-19 present a further illustrative embodiment of a telescopicclosure prosthesis in accordance with the disclosure. The prosthesis canbe delivered using the delivery catheter described herein above.

FIGS. 17A-17E illustrate particular structural aspects of the prosthesis1700. As illustrated, prosthesis 1700 includes a distal disc 1702 and aproximal disc 1712 as with preceding prostheses described herein,connected by a tension coil spring 1701. However, prosthesis 1700differs quite significantly in structure from any of the foregoingprostheses described herein. In pertinent part, although the discs 1702,1712 are formed of a braided material, they are not connected by braidedmaterial, but are instead connected by the spring 1701, as well as theillustrated expansion limiting tethers 1736, 1738. Prosthesis 1700 ispresented in a compacted form, as illustrated in FIG. 17D wherein thetension spring 1701 has fully collapsed the device axially. FIG. 17E, incontrast, illustrates the prosthesis 1700 in an axially expanded format.

Disc 1702 is also provided with a further structure, or “paddle” thatextends radially outwardly from the disc 1702 when deployed. The paddlecan be attached to the structure of the inner face of disc 1702 suchthat its orientation is parallel to a longitudinal axis of the deliverysystem when the prosthesis 1700 is collapsed. Since the paddle isattached to the planar inner face of disc 1702, it then reorients tobeing generally transverse, or even perpendicular, to the longitudinalaxis of the delivery system when deployed. If desired, the paddle can beattached to any face of the prosthesis 1700, depending on how it isbeing delivered. Moreover, multiple paddles can be provided attached tothe same or different discs. In one embodiment, two paddles are attachedto the proximal face of the distal disc rather than one as illustratedthat are positioned at the same general circumferential location of thedisc (next to each other) or spaced apart from each other, such as by180 degrees. In another embodiment, three or more (e.g., four five)paddles are provided that may be spaced from each othercircumferentially uniformly or non-uniformly.

The paddle can be a wire frame as depicted and may be partially orcompletely covered by synthetic or living tissue or graft material, ormay be uncovered. In the illustrated embodiment, a polyethyleneterephthalate (“PET”) fabric is used. Generally, with respect toprosthesis, fabric provided within the mesh discs (e.g., 1702) is madefrom a polyester with a non-stretchable weave, such as a braidedpolyester material. The material serves to reduce or prevent the flow ofblood across the disc 1702. The fabric is preferably between about 0.003to about 0.004 inches thick, and more generally can range from about0.0005 to about 0.010 inches thick, or any increment therebetween of0.0001 inches, as desired.

The outer fabric that resides over the neck region of the prosthesis1700, for example, is preferably a knitted polyester and hasconformability to the shape of the disc. Although this material isknitted and defines pores therein, it facilitates hemostasis, preferablyimmediate hemostasis, when disc 1702 is deployed. The material is alsosuitably configured to facilitate tissue ingrowth after implantation ofthe prosthesis. The outer fabric is preferably about 0.009 inches thick,and more generally can range from about 0.002 to about 0.010 inchesthick, or any increment therebetween of 0.001 inches, as desired.

In use, the paddle provides pullout resistance when the prosthesis isdeployed. Specifically, during delivery of the prosthesis, significantforce is exerted by the prosthesis against the inner arterial wall abovethe opening through which the prosthesis extends. The paddle extendsupwardly above the opening in the artery parallel to the direction ofthe artery. When the prosthesis is pulled on by the delivery system, thepaddle is urged against the arterial wall above the hall, and preventsthe prosthesis from being pulled out of the artery.

As can be appreciated from the figures, distal disc 1702 is configuredfor placement in an arterial environment, wherein graft material isdisposed in the disc in a manner similar to the embodiment of FIG. 1Cherein. Specifically, the distal face of the distal disc 1702 caninclude a first disc shape graft portion 1708 a that has a continuoussurface except for a small hole or aperture 1708 b at the center thereoffor surrounding the distal end of the coil spring 1701 where it meetsthe mesh to permit a guidewire to pass through the distal end of theprosthesis. This first disc shaped portion 1708 a can be joined aboutits outer periphery (e.g., by weaving or stitching) to a second discshaped portion 1708 c which also defines therein a central aperture 1708d which may be slightly larger than 1708 b to permit passagetherethrough of the coil spring 1701 which in turn is sized and shapedto permit passage therethrough of a pushrod (e.g., a stainless steel orNiTi hypotube, or polymeric (e.g., PEEK) or composite (e.g., carbonfiber) tubular member) of the delivery system containing the guidewire,as with the embodiment of FIG. 1. A further tubular graft portion 1708 ecan be attached to and depend in a proximal direction from the proximalface of second disc shaped portion 1708 c to line a neck region of thedistal disc 1702 and to surround a portion of the coil spring 1701. Incontrast to the embodiment of FIG. 1, distal disc 1702 of prosthesis1700 further includes a concave graft portion 1708 f defining anaperture 1708 g in a center thereof to accommodate the coil spring 1701,as well as a distal floating sleeve or marker band 1732 that isconfigured to slide over an outer surface of the coil spring 1701 whenthe spring expands, whereas the distal face of disc 1702 is attached atits central region to the coil spring 1701.

The graft portions 1708 a, 1708 c, 1708 e, 1708 f cooperate with theexterior surface of the spring 1701 to define an interior compartment1709 that can be used for a variety of purposes. For example,compartment 1709 can be used to include a beneficial agent, such as acoagulating gel, or other beneficial agent such as a pharmaceuticalcompound or other material. The concavity defined on the distal disc1702 permits the sleeve 1734 of the proximal disc to be nested withinthe mesh of the distal disc, thus permitting a very compactconfiguration if needed. Instead of or in addition to a woven graftmaterial, an elastic polymer and/or a hydrophilic polymer layer can besued to enhance closure and placement of prosthesis 1700, especially ina calcified fistula.

Proximal disc 1712 is similar in many respects to disc 112 of theembodiment of FIG. 1, except that it is not attached to the distal disc1712 at its distal end, and is instead attached to a proximal floatingsleeve or marker band 1734 that is configured to slide over an outersurface of spring 1701, as with distal floating sleeve or marker band1732. Discs 1702, 1712 are illustrated as being connected atsleeve/marker bands 1734, 1732 by way of expansion limiter tethers 1736,1738. The net result is that when the prosthesis 1700 is expandedaxially as illustrated in FIGS. 17A, 17E, the discs 1702, 1712 maintaina relaxed condition as when deployed fully until the expansion limitertethers 1736, 1738 begin to be placed under tension. When expansionlimiter tethers 1736, 1738 are placed under tension, the discs 1702,1712 will deform by decreasing in radial dimension, which can be usefulwhen loading the prosthesis 1700 into a delivery sheath as describedherein, or if it is desired to remove the prosthesis and reposition itin situ during the procedure. Expansion limiter tethers 1736, 1738further act to prevent the coil spring 1701 from being overly stretchedor yielded (e.g., deformed plastically), and can also act to hold theprosthesis 1700 together in the event that spring 1701 fractures.

Prosthesis 1700 provided additional advantages as compared to the otherprostheses described above. By virtue of the inner ends of the discs1702 and 1712 being able to freely slide over the coil tension spring1701 independently of each other, it is possible to have a trulytelescoping prosthesis. This permits the discs 1702, 1712 to be in anoptimal configuration when installed, yet allow for different distancesbetween the discs 1702, 1712, thus permitting a prosthesis 1700 of thesame design to be used in multiple patients having larger or smallerdistances between adjacent lumens that incorporate the prosthesis 1700.Further, the discs 1702, 1712 of prosthesis 1700 can be made in whole orin part from bioresorbable material metallic or polymeric materials.

In addition to providing true telescoping ability, decoupling the discs1702, 1712 from each other greatly facilitates articulation of theprosthesis. As seen in FIG. 18, the distal disc 1702 can easily bearticulated with respect to the proximal disc 1712, by an angle that isalmost 90 degrees (e.g., 60, 70, 80 degrees). If desired, a backend pushrod extension limiter 1780, such as in the form of a bushing over theshaft of the delivery catheter (FIG. 17F) can be provided to avoidoverly stretching the prosthesis axially.

The delivery system can be used to collapse discs for loading, fullretrieval even after full deployment and individual control of discs.For example, as illustrated in FIG. 19A, an implant is loaded within thedelivery system and delivered to a target site for deployment. Thedistal disc 1702 is then advanced from the catheter into an artery, forexample, as illustrated in FIG. 19B. FIG. 19C illustrates the distalaortic disc 1702 fully deployed, and preparing it to be seated. FIG. 19Dillustrates axial extension of spring 1701, by pushing on pushrod 180.The proximal venous disc 1712 is then deployed as shown in FIG. 19E.FIG. 19F illustrates the proximal venous disc 1712 in a fully deployedcondition to be seated. FIG. 19G illustrates releasing the prosthesis1700 from the delivery system, which can then be removed, as illustratedin FIG. 19H. It will be appreciated that the prosthesis of FIG. 19 isnot illustrated as having the paddle shown in other figures, but apaddle can be provided on the prosthesis if desired.

FIG. 20 illustrates further aspects of the prosthesis and deliverysystem, showing the advantages of using the paddle described above thatis attached to disc 1702. The prosthesis is illustrated in FIG. 20A in adeployed condition resting on the delivery system with a guidewirepassing through the central lumen of the system and out of the distalend. FIG. 20B illustrates the paddle framework independently of theprosthesis. As illustrated, the framework can simply be a loop ofmetallic or other suitable material that is then attached to theframework of the prosthesis 1700. Markers can be provided along aportion or the entirety of the paddle structure, or the paddle structurecan be formed of radiopaque material, for example, such as 70% NiTi and30% platinum wire, known as “DFT” wire.

FIG. 20C illustrates prosthesis 1700 in a collapsed condition with thepaddle attached to the disc 1702, and further wherein the paddleincludes graft material attached thereto. FIG. 20D illustrates aproximal-distal view of prosthesis mounted on the delivery system,illustrating the proximal face of the proximal disc. FIG. 20E is a sideview of the expanded prosthesis illustrating the positioning of thepaddle attached to the distal disc. FIGS. 20F and 20G further illustrateside views of the prosthesis 1700 particularly illustrating theplacement of graft material on the inner face of each of the proximaland distal discs and between the discs such that the graft materialforms a “saddle” shape that presents as a concave projection when viewedfrom the side that has a minimum diameter near the middle of the neckregion of the prosthesis 1700 that gradually widens toward each disc.This shape of the graft material as supported by the underlyingstructure of the prosthesis is believed to be advantageous in providingan effective seal after implantation, especially with respect to thearterial wall, such as the abdominal aorta. In some embodiments, theprosthesis 1700 is configured so as to not provide a complete seal withrespect to the proximal disc that urges against the inner wall of theinferior vena cava (IVC), for example. In certain instances, completesealing of the IVC of the implant may not be desired. This can be thecase where it is desired for the vein to intake blood that is leakedfrom the corresponding artery that is being sealed by the distal disc.In practice, since the vein may not have significant positive pressure,the need for sealing may be negligible, and it may be advantageous, infact, to maintain some degree of fluid communication between the veinand the space between the vessels via the hole in the vein as a part ofthe procedure.

FIG. 20H illustrates positioning of the delivery system that can beeffected by virtue of the flexible distal portion of intermediatetubular member 118. The flexibility of distal portion of intermediatetubular member 118 can be extremely advantageous as its flexibilitypermits it to be deformed into a geometry that permits it to effectivelybend about 90 degrees with respect to a central axis of a proximalportion of the delivery system, as illustrated in FIG. 20H.Specifically, when implanting the prosthesis 1700 on the arterial side,the paddle is urged against the upper (i.e., cranial) wall above thehole in the artery (e.g., the abdominal aorta) to prevent the prosthesis1700 from being pulled through the hole. However, during this alignmentstep, the paddle urging on the upper, inner wall of the artery canadvantageously be used as a fulcrum, or “pivot point” to rotate theprosthesis into alignment horizontally such that the lower portion ofthe distal disc is also pulled against the inner wall of the artery,below the access hole through which the prosthesis 1700 extends. Thismovement about the “fulcrum” is effectuated by exposing the distal,flexible portion of intermediate tubular member 118 and pushing thedelivery system distally into the vein (e.g., IVC) so that a bowing ofthe intermediate tubular member 118 occurs to obtain a serpentineconfiguration that resembles the shape of a reversed question mark(“?”), as illustrated in FIG. 20 by virtue of the prosthesis 1700 beingconstrained due to partial implantation. This maneuvering pulls theproximal face of the distal disc flush against the arterial wall,completing the implantation of the distal disc, and thus minimizingarterial leakage. It can be particularly advantageous to provide amarker at the base of the paddle where the paddle meets the prosthesisdistal disc, because such a marker, when so positioned, is very usefulfor indicating the location of the arterial hole under fluoroscopybecause the marker is thus located at the “fulcrum” or pivot point,discussed above. Including a fabric on the paddle can provide additionalresistance to pullout of the prosthesis during implantation as the innersurface of the arterial wall can be rough due to plaque formation. Thefabric of the paddle can urge against and somewhat adhere to this unevensurface, facilitating implantation of prosthesis 1700.

FIGS. 21A-E illustrate various stages of deployment of the prosthesiswith respect to the delivery system. FIG. 21A illustrates the prosthesis1700 in a deployed condition with the paddle extending radiallyoutwardly with respect to the prosthesis. As illustrated, the distal tip122 of the outer tubular member can be cut on a bevel to facilitateguiding the device across the wall of the inferior vena cava into theaorta, for example. It is also advantageous to provide a marker band, asillustrated, that is also in an angle at the beveled end of the distaltip 122. Such a marker band is very helpful in alignment of the devicein use, but it also informs the user when the distal tip 122 istraversing the walls of the artery and vein as it is being withdrawnproximally to implant the prosthesis 1700. The net result is that thebeveled end and marker permits superior alignment that helps reducetilting, or canting, of the prosthesis during implantation. This reducedcanting is further aided by the flexibility of the distal end of member118.

FIG. 21B illustrates the prosthesis 1700 in a semi-collapsed state,showing the rotation of the paddle (at upper right) from a radialoutward orientation toward an axial orientation to match the orientationof the proximal face of the distal disc. FIG. 21C shows the prosthesis1700 partially drawn proximally into the distal tip 122 of the deliverycatheter, whereas FIG. 21D shows the prosthesis fully withdrawnproximally into the delivery catheter. Finally, FIG. 21E shows thelateral orientation of the delivery system and prosthesis as it isenvisioned in use during the implantation procedure, with the paddleextending upwardly in an orientation where it can contact the arterialwall above the access opening.

FIG. 22 illustrates placement of the disclosed system in situ in actualuse, wherein the delivery catheter is advanced through the inferior venacava, and the guidewire and prosthesis extend into the abdominal aorta.As illustrated, portion 118 of the delivery system is permitted to flexinto the disclosed reverse question mark shape, facilitating alignmentand placement of the prosthesis 1700 by rotating the prosthesis aboutthe paddle that is urged against the arterial wall above the accessopening into the abdominal aorta. Also pointed out are the location ofthe marker at the base of the paddle, as well as the marker on thebeveled tip 122 of the delivery catheter.

In further accordance with the disclosure, embodiments are alsoprovided, but not specifically illustrated, that adds the tetheringfeatures of the embodiments of FIGS. 14-17 to any other embodimentdisclosed herein, including but not limited to the embodiments of any ofFIGS. 1-13, whether or not such embodiments are constructed with aresilient member or coil spring.

In further accordance with the disclosure, any prosthesis disclosedherein can be formed at least in part from a composite wire. In someembodiments, the composite wire can be drawn filled wire. For example,the drawn filled wire can include a first material, and a secondmaterial in a different region of the drawn filled wire that has greaterradiopacity than the first material. The first and second materials caninclude metallic components and/or bioresorbable components. If desired,the second material can be located along a core region of the wire, andfirst material can surround or substantially surround the firstmaterial. The first material can include a NiTi alloy, and the secondmaterial can include platinum, for example. Other suitable examples formaking such composite materials can be found in U.S. patent applicationSer. No. 10/524,387, filed Sep. 13, 2004, which is incorporated byreference herein in its entirety for any purpose whatsoever.

The devices disclosed herein can be implanted via the delivery system intransmural or transcameral applications using techniques similar tothose presented in International Patent Application No.PCT/US2013/072344, filed Nov. 27, 2013 and published Feb. 12, 2015 asWO/2015/020682 A1, which is incorporated by reference herein in itsentirety for any purpose whatsoever. However, the presently disclosedembodiments permit easier deployment, adjustment, and retrievability byvirtue of the elastic member and pushrod, among other things.

Thus, an exemplary method for use of any of the devices herein can be inconjunction with a method of transcatheter delivery of a device to thecardiovascular system. The method can include advancing a puncturedevice through a femoral vein to a venous crossing site, the venouscrossing site being located along an iliac vein or the inferior venacava. The method can further include using the puncture device topuncture a venous wall at the venous crossing site and then puncture anadjacent arterial wall at an arterial crossing site. The arterialcrossing site is preferably located along an iliac artery or theabdominal aorta. The method can further include advancing at least aportion of the puncture device into the iliac artery or the abdominalaorta, thereby forming an access tract between the venous crossing siteand the arterial crossing site.

The method can further include advancing a catheter through the accesstract from the venous crossing site to the arterial crossing site, anddelivering the device into the iliac artery or the abdominal aortathrough the catheter. The device can be a prosthetic heart valve, aorticendograft, left ventricular assist device, or cardiopulmonary bypassdevice among other potential devices. In some embodiments, the puncturedevice can be selectively electrically energized to puncture the venouswall and the arterial wall. The puncture device can include inner andouter coaxial members, wherein the inner member comprises a guide wireor needle that is advanced to initially puncture the venous and arterialwalls, and the outer member can be advanced over the inner member toenlarge the initial punctures and facilitate introduction of largerdevices through the access tract. A target device can be advancedthrough a peripheral artery to adjacent the arterial crossing site. Thetarget device can be used to guide an operator in directing the path ofthe puncture device through the arterial wall and into the iliac arteryor the abdominal aorta.

After the access tract is formed, a guidewire can be introduced throughthe access tract. The catheter can then be advanced over the guidewirethrough the access tract into the iliac artery or the abdominal aorta todeliver the device. After delivering the device, an occlusion device asdescribed herein can be delivered over a guidewire into the access tractto close the access tract. The occlusion device is preferably radiallycompressible for transcatheter delivery and radially expandable forimplantation. The occlusion device can include an arterial portion forplacement at the arterial crossing site, a venous portion for placementat the venous crossing site, and a neck portion for placement in theaccess tract. The occlusion device can include a guidewire channelextending through the venous portion, the neck portion, and the arterialportion. This portion of the procedure can be implemented by deploying adelivery catheter as disclosed herein and advancing it into the arteryand deploying a first portion, such as a lobe or disc, of the prosthesisinto the artery, optionally deploying one or more discs between theartery and vein, and deploying a disc or lobe into the vein. If theprosthesis includes a spring as described herein or tethers, the devicecan be collapsed by pushing on the push rod to partially collapse theprosthesis to permit it to be repositioned and redeployed, or fullycollapsed and withdrawn back into the delivery system. The implant ispreferably configured to be implanted across an arteriovenous fistula ortract connection between an artery and a vein with the arterial endportion positioned in the artery, wherein the venous end portion ispositioned in the vein, and a neck portion is positioned in the fistulaor tract connection.

The systems disclosed herein can be used to close congenital heartdefects including atrial septal defect, ventricular septal defect,persistently patent ductus arteriosus. The system can be used to closediatrogenic heart defects including extra-anatomic vascular access portsfrom the chest across the wall of the left or right ventricle into therespective lumen, or from the chest across the wall of the left or rightatrium into the respective lumen, both to achieve temporarytranscatheter access to the heart to allow therapeutic catheterinterventional procedures or implantation such as mitral valve ortricuspid valve or aortic valve or pulmonic valve or prosthesis orannuloplasty implantation or modification or repair of Paravalvularleaks.

All statements herein reciting principles, aspects, and embodiments ofthe invention, as well as specific examples thereof, are intended toencompass both structural and functional equivalents thereof.Additionally, it is intended that such equivalents include bothcurrently known equivalents as well as equivalents developed in thefuture, i.e., any elements developed that perform the same function,regardless of structure.

The methods and systems of the present disclosure, as described aboveand shown in the drawings, provide for improved techniques for treatinglumenal systems of patients. It will be apparent to those skilled in theart that various modifications and variations can be made in thedevices, methods and systems of the present disclosure without departingfrom the spirit or scope of the disclosure. Thus, it is intended thatthe present disclosure include modifications and variations that arewithin the scope of the subject disclosure and equivalents.

What is claimed is:
 1. A prosthesis comprising: a) a radially expandablemesh body that is configured to self-expand into at least one disc afterbecoming radially unconstrained, the radially expandable mesh bodydefining a volume therein when expanded, the at least one disc includinga deployable paddle attached to a proximal or distal face the at leastone disc, the paddle being configured to assume a radial orientation asthe at least one disc expands outwardly radially, the deployable paddlebeing configured to extend radially outwardly beyond the at least onedisc; and b) a resilient member disposed within the mesh that isattached to a proximal end and distal end of the prosthesis along anaxis that defines a central region of the prosthesis, the resilientmember being configured to cause the prosthesis to shorten along theaxis and expand radially when the resilient member is relaxed.
 2. Theprosthesis of claim 1, wherein the prosthesis includes a materialdisposed within the mesh that is configured to encourage hemostasis whenexposed to blood.
 3. The prosthesis of claim 2, wherein the materialdisposed within the mesh includes first and second fabric discs that aredisposed within the at least one disc of the radially expandable meshbody to line the radially expandable mesh body with fabric.
 4. Theprosthesis of claim 3, further comprising a tubular fabric portionattached to at least one of the fabric discs, the tubular fabric portionextending proximally into a neck region of the prosthesis.
 5. Theprosthesis of claim 1, wherein the resilient member is a coil springthat causes the prosthesis to collapse axially and the at least one discto expand radially to prevent the prosthesis from being pulled axiallythrough an anatomical opening it has been delivered through after it hasbeen deployed.
 6. The prosthesis of claim 1, wherein the resilientmember is a tension coil spring.
 7. The prosthesis of claim 6, whereinthe coil spring includes a plurality of sections of different diameter.8. The prosthesis of claim 6, wherein the coil spring includes at leastthree sections of different diameter.
 9. The prosthesis of claim 6,wherein the coil spring includes at least three sections wherein eachsection has a diameter different than an adjacent section.
 10. Theprosthesis of claim 6, wherein the coil spring includes an enlargedcentral section for causing a neck portion of the prosthesis to bulgeradially outwardly when the prosthesis is deployed.
 11. The prosthesisof claim 1, wherein the radially expandable mesh body is configured toself-expand into at least two discs connected by the neck region afterbecoming radially unconstrained, a first disc of the two discs beingconfigured to mitigate high pressure leaks in an artery, and a seconddisc of the two discs being configured to mitigate low pressure leaksoriginating from a vein, and further wherein the neck region isconfigured to cooperate with the first and second discs to preventleakage from the artery and the vein.
 12. The prosthesis of claim 11,wherein at least one of the discs includes a plurality of radiallyoriented struts attached to the mesh of the at least one disc to enhancethe axial compressibility of the prosthesis.
 13. The prosthesis of claim12, wherein the prosthesis includes a plurality of radially orientedstruts attached to the discs at the distal and proximal faces of theprosthesis, extending from a radially central portion of the prosthesisto an outer periphery of the prosthesis.
 14. A system for delivering aprosthesis, comprising: a) an outer tubular sheath having a proximal endand a distal end and defining a first lumen therethrough along itslength, the distal end of the outer tubular member being cut at an anglethat is oblique with respect to a central axis defined by the system,the distal end further including a radiopaque marker proximate thedistal end making the angle at which the distal end is cut being visibleunder fluoroscopy to help reduce canting of the prosthesis duringimplantation; b) an intermediate tubular member disposed at leastpartially within the first lumen, and having a proximal end and aflexible distal portion and defining a second lumen therethrough alongits length, the flexibility of distal portion of the intermediatetubular member being configured to permit the intermediate tubularmember to be deformed into a geometry that permits it to effectivelybend about 90 degrees with respect to a central axis of a proximalportion of the delivery system; c) an inner elongate member disposed atleast partially within the second lumen, and having a proximal end and adistal end; and d) a prosthesis removably mounted on the distal end ofthe intermediate tubular member, the prosthesis including: i) a radiallyexpandable mesh body that is configured to self-expand into at least onedisc after becoming radially unconstrained, the radially expandable meshbody defining a volume therein when expanded, the at least one discincluding a deployable paddle attached to a proximal or distal face theat least one disc, the paddle being configured to assume a radialorientation as the at least one disc expands outwardly radially, thedeployable paddle being configured to extend radially outwardly beyondthe at least one disc; and ii) a resilient member disposed within themesh that is attached to a proximal end and distal end of the prosthesisalong an axis that defines a central region of the prosthesis, theresilient member being configured to cause the prosthesis to shortenalong the axis and expand radially when the resilient member is relaxed,and wherein distal movement of the inner tubular member against aportion of the prosthesis causes it to collapse radially and elongateaxially so as to permit the prosthesis to be collapsed after deployment,adjusted and redeployed or retracted into the outer tubular member andremoved.
 15. The system of claim 14, wherein the inner elongate memberis a tubular member configured to permit a guidewire to passtherethrough.
 16. The system of claim 14, wherein the resilient memberis a coil spring that causes the prosthesis to collapse axially and theat least one disc to expand radially to prevent the prosthesis frombeing pulled axially through an anatomical opening it has been deliveredthrough after it has been deployed.
 17. The system of claim 16, whereinthe resilient member is a tension coil spring.
 18. The system of claim14, wherein the system includes a steering mechanism to articulate thedistal end of the outer tubular member, such that the oblique cut of thedistal end of the outer tubular member can facilitate navigation of thedistal end of the system through a caval-aortic iatrogenic fistulacreated by the introduction of a transcatheter device from the inferiorvena cava into the abdominal aorta.
 19. The system of claim 16, whereinthe coil spring includes an enlarged central section for causing theneck portion of the prosthesis to bulge radially outwardly when theprosthesis is deployed.
 20. The system of claim 19, wherein the radiallyexpandable mesh body is configured to self-expand into at least twodiscs connected by the neck region after becoming radiallyunconstrained, a first disc of the two discs being configured tomitigate high pressure leaks in an artery, and a second disc of the twodiscs being configured to mitigate low pressure leaks originating from avein, and further wherein the neck region is configured to cooperatewith the first and second discs to prevent leakage from the artery andthe vein.